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Plain-language guide to NCT00492934: not phased randomized trial of HMG (Human Menopausal Gonadotropin), 300 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT00492934
Phase
not phased
Status
status unknown
Start
2004-01
Completion (planned or actual)
2013-10
Participants
300 (estimated)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Infertility
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around HMG (Human Menopausal Gonadotropin).

It had two arms (groups): 1 (active comparator) and 2 (no intervention).

No daily injections with hormones.

The registry classes the interventions as drug.

Who Took Part

The registry lists 300 planned participants were the target.

It was open to women only aged from 21 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Signed informed consent. Women with a regular cycle (between 21 and 35 days). Embryo and endometrium are synchronized.

The full record lists 4 inclusion and 1 exclusion criteria; among the exclusions: embryo storage time not longer than 5 years.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the HMG (Human Menopausal Gonadotropin) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when HMG (Human Menopausal Gonadotropin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2004-01 with completion listed for 2013-10.

It ran at 1 site in Belgium.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: implantation rate per embryo (time frame: 15 days after the embryo transfer).

It also tracked 1 secondary outcome, for example thickness of the endometrium.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of HMG (Human Menopausal Gonadotropin) in 300 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the HMG (Human Menopausal Gonadotropin) compound page, all human trials.

Our Notes on the Compound

HMG (Human Menopausal Gonadotropin): Menotropins: a glycoprotein preparation that supplies follicle-stimulating hormone (FSH) and luteinizing hormone (LH) activity.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.